Download Children With Special Health Care Needs Program, Wadsworth Center Newborn Screening Program - Criteria for Approval of Cystic Fibrosis Specialty Centers

NEW YORK STATE DEPARTMENT OF HEALTH
CHILDREN WITH SPECIAL HEALTH CARE NEEDS PROGRAM WADSWORTH CENTER NEWBORN SCREENING PROGRAM Criteria for Approval of Cystic Fibrosis Specialty Centers A Cystic Fibrosis (CF) Center is defined as an Article 28 general hospital that has at least one cystic
fibrosis specialist. In addition to meeting the requirements specified for a general hospital in New
York Codes, Rules and Regulations (NYCRR), Title 10, Part 405, a Cystic Fibrosis Center will meet
the criteria specified below. If the Cystic Fibrosis Center will operate at more than one location, each
sub site must be identified.1
I.
Hospital Administration
Administration shall be responsible for:
•
general operation of the center in accordance with written policies and procedures;
•
employment or availability of qualified personnel, who maintain privileges at the
hospital;
•
compiling of statistical data, and review and revision of reporting systems and data
collection;
•
providing an annual update of all changes in personnel;
II. Specialty Center Facilities
Specialty Center facilities must include:
•
inpatient and outpatient facilities available according to the needs of the individual
patient;
•
dedicated pediatric inpatient beds, neonatal intensive care unit as part of a level III
perinatal program2 and pediatric intensive care unit3;
•
onsite facilities for standard clinical-pathological studies, radiological studies
(i.e. X-rays, sonogram, CT, MRI) electrocardiogram studies, electroencephalogram
studies and nuclear medicine studies;
•
respiratory care department, with respiratory therapy available 24 hours a day,
7 days a week. Services would also include the ability to do pulmonary function tests,
including ability to measure lung volumes in pediatric patients; and
•
laboratory capability for all necessary studies as specified by the New York State
Newborn Screening Program and the Wadsworth Laboratories.
1
The Permanent Facility Indicator (PFI) will identify the Cystic Fibrosis Center in the application. If the Cystic Fibrosis Center will operate at more than one location, each sub site must be specified by address and PFI number in the application.
Each sub site will: a) be on the operating certificate of the Article 28 facility that is the main site; b) be identified by a PFI number; c) have physician specialists that have admitting privileges to the main site; and d) assure access to all services at the main site specified in these criteria. 2
If the hospital does not provide maternity services, then a neonatal intensive care unit is not required.
3
If the hospital does not have a pediatric intensive care unit (PICU), then a protocol must be described for emergent care, appropriate pediatric transport, and continuity of CF care. Criteria for Cystic Fibrosis
April 2003
Page 1 of 3
Updated May 7, 2009
In addition to standard clinical studies the laboratory shall have the capability to perform sweat tests by
quantitative pilocarpine ionophoresis (in accordance with the NCCLS document) onsite and the
following other core tests either onsite or by referral to another New York State approved laboratory:
1. Bacteriology
2. Blood chemistries
3. Arterial blood gases
III.
Specialty Center Personnel
A.
Core Personnel
The core personnel consist of a medical director and any additional cystic fibrosis
specialist.
A.1.
Medical Director, Cystic Fibrosis Center
The medical director shall:
• be a cystic fibrosis specialist. A cystic fibrosis specialist is defined as either
a board certified/eligible pediatric pulmonologist, pediatric
gastroenterologist, or a board certified pediatrician with at least 5 years
experience post-residency treating children with cystic fibrosis.
• assure that all children referred to the center are seen by the director or
another cystic fibrosis specialist.
A.2.
Cystic Fibrosis Specialist
The Cystic fibrosis specialist will assure:
• each child referred to the center receives an initial comprehensive
evaluation, on an inpatient or outpatient basis, as indicated. The
comprehensive evaluation includes a medical, psychological and social
history, physical examination and appropriate diagnostic studies;
• appropriate treatment of the child is initiated, and assure the development
and implementation of a plan for ongoing management with parental
involvement;
• supportive services are in place to assist families with identifying resources
and applying for benefit programs related to the financial aspects of care,
education about the disorder and training about self-care for patients and
their families;
• the child has a primary care provider;
• adequate and prompt reports on clinical evaluations, recommendations for
treatment and follow-up and other necessary records are provided to
referring physicians and, when requested, to the screening laboratory;
• guidance is provided for transitioning to adult care; and
• appropriate evaluation for patients already under treatment at the time of
referral.
Criteria for Cystic Fibrosis
April 2003
Page 2 of 3
Updated May 7, 2009
B. Other Core Personnel
The following personnel shall be available onsite for consultation:
•
Medical Social Worker;
•
Registered Dietician or Certified Dietician/Nutritionist;
•
Licensed Respiratory Therapist;
•
Registered Nurse Coordinator; and
•
Laboratory Director who meets the qualifications specified in
Part 19 Clinical Laboratory Directors, Section 19.2-19.4, Title 10, Official
Compilation of Codes, Rules and Regulations of the State of New York. The
Laboratory Director’s Certificate of Qualification as issued by the NYS Clinical
Laboratory Evaluation Program (CLEP) must include:
1. Bacteriology
2. Clinical Chemistry
3. Blood pH and Gases
C.
Reference: Additional Personnel
Consultation shall be available onsite or by referral in all specialties related to the care
of the patient, including:
• board certified/eligible clinical geneticist
• genetic counselor who is board certified or an active candidate for certification;
• board certified/eligible pediatric pulmonologist;
• board certified/eligible pediatric gastroenterologist;
• recognized developmental specialist (a board certified/eligible developmental
pediatrician, a board certified/eligible pediatric neurologist, or a licensed
psychologist);
• board certified/eligible pediatric radiologist;
• board certified/eligible specialist in nuclear medicine;
• board certified/eligible pediatric urologist;
• board certified/eligible pediatric surgeon;
• board certified/eligible pediatric otorhinolaryngologist;
• board certified/eligible pediatric allergist/immunologist;
• board certified/eligible pediatric cardiologist;
• board certified/eligible pediatric endocrinologist; and
• board certified/eligible pediatric infectious diseases specialist.
Clinical Practice Guidelines for Cystic Fibrosis.
Cystic Fibrosis Foundation, Bethseda, Maryland, 1997.
Criteria for Cystic Fibrosis
April 2003
Page 3 of 3
Updated May 7, 2009